Ethics in Nursing Research

Mohammad Aloufi
Chapter Objectives
• By the end of this topic and with further reading and research, you
are expected to:
• Recognize the precise guidance and codes of ethics concerning
nursing research
• Discuss the historical background that underpins the creation of the
codes of ethics
• Recognize the important legislation that nurse researchers need to
consider
• Appreciate the principles required to undertake good research
practice
• Be familiarize with research ethics in Saudi Arabia
5.1. Introduction
• The term research ethics refers to a wide variety of values,
norms, and institutional arrangements that help constitute
and regulate scientific activities.
• Research ethics is a codification of scientific morality in
practice.
• Guidelines for research ethics specify the basic norms and
values of the research community.
• They are based on general ethics of science; just as general
ethics is based on the morality of society at large.
5.1. Introduction
• For research to be conducted, ethical approval is required
from a research ethics committee or institutional review
board to preserve the rights, security, and wellbeing of
participants.
• Numerous institutions have developed a code of ethics that
members or workers are expected to follow.
• Nursing research adheres to similar ethical standards like all
other research concerning human participants.
5.2. Historical Background
• Ethics codes development has evolved only after1940's, partially
due to some rather poor practice and to a long and harrowing
background of violations against human rights, to protect subjects
from scientific abuses.
• For example:
• The Tuskegee Syphilis research in 1923–1972, in which the
evolution of syphilis in black men was traced after they were
unknowingly infected.
• The Willowbrook study conducted in the late 1950s, persisted 14
years and included purposely giving mentally challenged children
the hepatitis.
• The Jewish Chronic Disease Hospital study in the 1960s, where 22
old senile subjects were injected with live cancer cells.
5.2. Historical Background
The activities as such medical unethical experiments
motivated the creation of number of code of ethics such as:
• The Nuremberg code and,
• The Helsinki declaration

In terms of nursing,
• The original inquiry was the "Nightingale Pledge" in 1983.
• Then The American nurses' association (ANA) guidelines for
research in 1985.
• And lastly, The International Council of Nurses ICN in 2012
has developed a code of ethics called ICN Code of Ethics for
Nurses (2012).
5.3. Environment for Ethical Research
Research should be supervised by an ethical engagement to
preserve the rights of individuals, including these main
principles:
• Respect for human dignity; informed, deliberate consent
without pressure and ability to withdraw from the study;
beneficence or “doing good”; non-malfeasance or “doing no
evil”; justice; veracity or “being upfront and truthful at all
times”; and confidentiality.
• These principles should also protect high standards of
integrity in the nurse, between research co-workers and
organizations, and in regards to the validity and reliability of
the research itself
5.4 Informed consent

• ”It means that a person knowingly, voluntarily and

intelligently, and in a clear and manifest way, gives his
consent" (Armiger, 1977).
This means;
• A) Have sufficient detailed explanation regarding the
research (objective, risks/benefits, alternative solutions,
whom to contact in case of questions or concerns...) and the
participant’s role in it,
• B) Comprehend the information, and
• C) Have the power of free choice, allowing them to agree to
or reject participation voluntarily
5.4 Informed consent
Informed Consent should contain (Cabanto, 2013):

• Participant Status • Potential benefits

• Study Goals • Alternatives
• Type of data • Compensation
• Procedures • Confidentiality Pledge
• Nature of the Commitment • Voluntary consent
• Sponsorship • Right to withdraw and
• Participant selection withhold information
• Potential risks • Contact information
5.5. Beneficence
Another term for beneficence is non-malfeasance
• "beneficence relates to the benefits of the research, while
non-malfeasance relates to the potential risks of
participation"(Ford & Reutter, 1990).
• Researchers must:
• A) predict and assessing potential risks (type, number and
degree) and minimize any foreseeable risks and
• B) form a contingency strategy for subjects opting to
discontinue their participation in the investigation.
5.6. Anonymity and Confidentiality

• Confidentiality refers to individuals being fully anonymous,

and since the subject's identity has been revealed to the
researchers, true anonymity is not achievable.
• Whereas anonymity is a form of confidentiality, where
participants’ identities are kept secret (data do not include
any information that can be used to identify the participant).

• Participants should also be informed of where their data will

be stored, for how long (usually defined by ethics boards of
5–7 years), and how it will be destroyed.
5.7. Justice
• As per the rule of justice, researchers are obliged to treat
subjects reasonably and fairly all through the study
procedures.
• Also, justice is guaranteeing that all people in the community
from all groups, with no consideration of vulnerability, can
profit by being included in the study.
5.8. Veracity
• The principle of veracity includes the duty of the researcher
to frankly present the study with no deception. People
reserve the privilege to be told the truth and not to be
beguiled about any part of the research (Parahoo, 2014)

• For instance, all participants should be informed about

expected involvement, the period (time commitment), what
happens to their information, and who will have access to
the data.
5.9. Fidelity
• The principle of fidelity is the give-and-take trust between
the researcher and participants and includes also the
researcher keeping confidentiality (Doody & Noonan, 2016).
• On consenting to partake in a study, subjects are entrusting
themselves to the researcher, and it is basic that researchers
in their turn be transparent and frank enabling participants
to make proper informed decisions.
• Subjects must acknowledge that they can withdraw at any
point of the study with no consequences
5.11. Research misconduct
• Research misconduct includes several forms of unacceptable
practices such as:

A) Fabrication: creating false data or other aspects of

research, including documentation and participants consent,
B) Falsifications: manipulating and selecting data, imagery or
consents,
C) Plagiarism: absence of acknowledgement/permission of
the direct use of others’ ideas, intellectual property or work,
5.12. Vulnerable groups
Another important feature that had drawn higher
concern nowadays in considering the ethics of nursing
research or human research in general happens when
the participants are part of a vulnerable group ,,,

It might combine:
• Individuals unable to provide informed consent,
including children or mentally ill persons
• Individuals at great risk of exploitation due to
limitations in personal power, such as prisoners
• Groups such as Indigenous societies
5.14. Research Ethics in Saudi Arabia
• The National Committee of Bioethics (NCBE) was developed in
2001 as a service centre for all parties concerned with biomedical
research in the Kingdom.
• Committee matters constitute biomedical research ethics, and
associated uses in hospitals, universities, and research institutes.
• It aimed to promote and improve all health, preventive,
diagnostic, remedial, psychological, social, and living features of
life, with maintaining human dignity, supporting charity, justice,
personal and societal rights, in a way compatible with the Islamic
Sharia (law), and the traditions and culture of the Kingdom of
Saudi Arabia.
• Saudi Arabia is considered one of the few Arab countries in
the Middle East that has national regulations that monitor
biomedical research.